Noninvasive vagus nerve stimulation to reduce ileus after major colorectal surgery: early development study.
ileus
noninvasive vagus nerve stimulation
surgery
vagus nerve
Journal
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
ISSN: 1463-1318
Titre abrégé: Colorectal Dis
Pays: England
ID NLM: 100883611
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
revised:
20
01
2021
received:
02
12
2020
accepted:
28
01
2021
pubmed:
5
2
2021
medline:
1
9
2021
entrez:
4
2
2021
Statut:
ppublish
Résumé
Vagus nerve stimulation has emerged as a plausible intervention to reduce ileus after surgery. An early development study was undertaken with the aim of exploring the feasibility of self-administered, noninvasive vagus nerve stimulation (nVNS) after major colorectal surgery. A parallel-group, randomized controlled trial was undertaken between 1 January 2018 and 31 August 2019. Forty patients undergoing colorectal surgery for malignancy were allocated equally to Sham and Active stimulation groups. Electrical vagus nerve stimulation was self-administered bilaterally over the cervical surface landmarks for 5 days before and after surgery. Outcomes of interest were postoperative complications and adverse events measured using the Clavien-Dindo scale, treatment compliance, device usability according to the Systems Usability Scale (SUS) and clinical measures of bowel recovery. Forty patients were randomized and one withdrew, leaving 39 for analysis. Postoperative complications occurred in 9/19 (47.4%) participants receiving Sham and 11/20 (55.0%) receiving Active stimulation and were mostly minor. Compliance with treatment before surgery was 4.7 ± 0.9 days out of 5 days in the Sham group and 4.7 ± 1.1 in the Active group. Compliance with treatment after surgery was 4.1 ± 1.1 and 4.4 ± 1.5, respectively. Participants considered the intervention to be 'acceptable' according to the SUS. The most prominent differences in bowel recovery were days to first flatus (2.35 ± 1.32 vs 1.65 ± 0.88) and tolerance of solid diet (2.18 ± 2.21 vs 1.75 ± 0.91) for Sham and Active groups, respectively. This study supports the safety, treatment compliance and usability of self-administered nVNS in patients undergoing major colorectal surgery.
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1225-1232Subventions
Organisme : Department of Health
ID : DRF-2018-11-ST2-049
Pays : United Kingdom
Organisme : NIHR Surgical MedTech Co-operative
Organisme : Bowel Research UK
Informations de copyright
© 2021 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.
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